Kathleen M. Fox, PhD

 To estimate the costs associated with home administration of oral paclitaxel and encequidar (novel P-glycoprotein pump inhibitor allowing oral paclitaxel bioavailability) compared with clinic/office administration of intravenous (IV) paclitaxel (175 mg/m

) and protein-bound paclitaxel in US patients with metastatic breast cancer.

A cost calculator was constructed from a payer’s perspective including all costs related to administration of the chemotherapies, including drug administration, premedications and concomitant medications, oncologist office visits, laboratory testing, and administration-related adverse events. Total administration cost per patient per month (PPPM) and 6-month costs per patient were estimated for oral paclitaxel and encequidar, 175 mg/m2 IV paclitaxel, and protein-bound paclitaxel. Three scenarios for oral paclitaxel and encequidar, a weekly IV paclitaxel scenario (80-100 mg/m

), and univariate sensitivity analyses were conducted.

 Home administration of oral paclitaxel and encequidar was associated with a total administration cost of $523 PPPM, 64.4% lower than once-every-3-weeks IV paclitaxel (175 mg/m

; $1469 PPPM) and 63.8% lower than protein-bound paclitaxel (260 mg/m

; $1445 PPPM). Difference in costs was driven largely by higher administration and premedication costs associated with IV therapies. Scenario analyses showed that increased clinical experience with home administration of oral paclitaxel and encequidar was associated with reduction in cost of care associated with its administration over time. For the weekly IV (80-100 mg/m

) paclitaxel scenario, the total administration cost was $2510 PPPM (4.8 times higher than for oral paclitaxel and encequidar). Univariate sensitivity analysis demonstrated that the model findings were robust.

: Home administration of oral paclitaxel and encequidar was associated with lower administration costs compared with once-every-3-weeks IV paclitaxel (175 mg/m

) and protein-bound paclitaxel, resulting in potential cost savings for payers.

 2021;27(Spec 2). Published online December 24, 2020. 

Home administration of oral paclitaxel and encequidar was associated with a total administration cost of $523 per patient per month (PPPM), 64.4% lower than intravenous (IV) administration of paclitaxel (175 mg/m2; $1469 PPPM) and 63.8% lower than protein-bound paclitaxel (260 mg/m2; $1445 PPPM) in patients with metastatic breast cancer.

• Conventional cytotoxic IV chemotherapies require substantial resources at the place of infusion and are associated with severe toxicities.

• Encequidar, a highly selective P-glycoprotein inhibitor, allows absorption of oral paclitaxel into the bloodstream, thereby eliminating infusion-related adverse effects.

• Findings from this study indicate that home administration of oral paclitaxel and encequidar may result in cost savings for payers.

According to National Comprehensive Cancer Network guidelines, sequential single-agent cytotoxic chemotherapy, such as paclitaxel or protein-bound paclitaxel, is recommended for recurrent or metastatic breast cancer (mBC).

For patients with incurable malignancies, when oral drugs’ efficacy and adverse effect (AE) profiles are comparable with those of intravenous (IV) options, the oral drugs are perceived to afford a greater quality of life.2 Benefits of oral administration may include patient convenience and reduction of discomfort due to avoidance of hospital and infusion center visits for invasive drug administration. Avoidance of IV drug administration eliminates the risk of infusion reactions and the need for premedication with agents such as steroids and antihistamines.

In addition, oral chemotherapy might be associated with cost savings, given that less time is required in clinic because of home administration.

 Among IV and oral chemotherapies of similar efficacy, surveys have shown that most patients would prefer oral over IV chemotherapy.

To date, oral formulations of agents such as paclitaxel have not been possible because of poor absorption into the bloodstream as a result of the active excretion by P-glycoprotein (P-gp). P-gp is an active efflux pump that prevents the absorption of substrates (such as taxanes) across the intestinal epithelium into the systemic circulation.

 Encequidar is an investigational, potent, highly selective P-gp inhibitor that blocks intestinal P-gp, allowing for better absorption of oral paclitaxel into the bloodstream, thereby eliminating the infusion-related AEs associated with IV paclitaxel.

 Oral paclitaxel and encequidar is the first oral taxane plus P-gp inhibitor that demonstrated a significant improvement in confirmed overall response rate and overall survival compared with IV paclitaxel in findings from its phase 3 trial. Compared with IV paclitaxel, this oral therapy was also associated with a lower risk of neuropathy and alopecia but a higher incidence of hematologic and gastrointestinal AEs.

The objective of this study was to estimate the costs associated with home administration of oral paclitaxel and encequidar compared with clinic/office administration of IV paclitaxel (175 mg/m

) and protein-bound paclitaxel from a US payer perspective in patients with mBC. 


A Microsoft Excel–based cost-calculator model was constructed from a US payer perspective to calculate aggregated costs associated with home administration of oral therapy vs clinic/office administration of IV therapy over a 6-month treatment duration (

The target population for this model included patients with mBC with any receptor status. For the base case analysis, a health plan with 10,000 treated patients with mBC was assumed, with 30% assumed to have Medicare insurance. The model evaluates patients starting on the following treatments:

: home administration (both medications are taken once daily for 3 consecutive days each week)
• (B) I

): office/clinic infusion (once every 3 weeks)
• (C) 

): office/clinic infusion (once every 3 weeks)

The cost-calculator model included all direct costs (pertaining to payers) related to administration of the oral or IV therapies; these included drug administration (drug preparation and equipment, supplies and resources required for administration), premedications and concomitant medications, oncologist office visits, laboratory testing, and administration-related AEs. Administration-related costs included any costs associated with the administration, including use of local anesthesia; IV access; access to indwelling IV, subcutaneous catheter, or port; flush at conclusion of infusion; standard tubing, syringes, and supplies; and preparation of chemotherapy agent.

 Laboratory testing included routine tests conducted alongside chemotherapy, including complete blood count (CBC) and comprehensive metabolic panel (CMP). Only AEs of grade 3 or 4 directly related to administration route (oral and IV) were included in the model (ie, allergic and injection site/infusion reactions, nausea/vomiting, diarrhea).


The model considers only outcomes and costs that are associated with the specific route and setting of administration of each drug therapy, including severe administration-related AEs (ie, grade 3 or 4). Since the focus of the study was to estimate costs associated with administration only, the drug costs of encequidar, oral paclitaxel, IV paclitaxel, and protein-bound paclitaxel were not included in the analysis. The drug-specific clinical efficacy (eg, overall survival) and AEs (other than administration-related) were considered equal and were not included in this analysis. All patients were assumed to be on chemotherapy for the entire 6 months with 100% adherence to medication and office visit and lab testing schedules. To make comparisons uniform, each month was assumed to be composed of 28 days, and all therapies were assumed to have started on week 1 of the first month.

summarizes the input parameters and data sources included in the model. The model was populated with data from 3 primary sources: a targeted review of the peer-reviewed literature, the preliminary AE rates of oral paclitaxel and encequidar from the phase 3 clinical trial,

 and expert oncologist opinion. Three breast cancer oncologists (experts) based in large academic institutions in different US geographic locations, with a mean of 8 to 10 years of clinical practice experience, were interviewed to obtain their opinions on practice patterns with IV and oral therapies in patients with mBC. Specifically, the interviews aimed to capture data about: (1) drug administration schedule, including premedications; (2) the frequency of oncologist visits, home nurse visits, and lab testing; (3) premedications; (4) monitoring of patients for AEs; and (5) administration-related AE risk. Two rounds of teleconference panel sessions were conducted with the experts to obtain data. The first session with each expert was a 1:1 interview, and the second interview session was a group interview that involved discussion of previous answers to reach consensus among the experts.



For oral paclitaxel and encequidar, base case analysis data for frequency of oncologist office visits and lab testing were obtained from expert interviews. The dosing schedule for oral paclitaxel and encequidar was provided by Athenex’s product information. For IV paclitaxel (175 mg/m

) and protein-bound paclitaxel, frequency of IV administration was captured from their package inserts.

Frequency of oncologist visits and lab testing for IV therapies was derived from expert opinion.

For all therapies, cost of an oncologist visit was derived from the 2020 CMS Physician Fee Schedule.12 Medicare costs for lab testing (CBC and CMP) were derived from the 2020 Clinical Laboratory Fee Schedule. Commercial/private insurer costs for lab testing were based on mean commercial reimbursement amounts obtained from laboratory pricing and reimbursement data available from Sparrow Health System.

Cost for premedication (the antiemetic ondansetron) for oral paclitaxel and encequidar was estimated from 2020 Average Sales Pricing data from CMS.

For IV and protein-bound paclitaxel, administration and premedication/concomitant medication costs were estimated from a retrospective database study evaluating the cost components for administering a single-agent IV breast cancer drug to women with mBC in the United States.

 Based on the distribution of individual components in mean cost per IV-administration visit, costs for administration and premedication/concomitant medications were estimated for IV paclitaxel and protein-bound paclitaxel. Premedications/concomitant medications for IV therapies included antiemetic agents (eg, palonosetron, granisetron), saline solution, dextrose water, corticosteroids (eg, dexamethasone), heparin, antihistamine (eg, diphenhydramine), and histamine-2 receptor antagonists (eg, ranitidine). 

Only those AEs of grade 3 or 4 that were related to the specific route of administration were included in the model (ie, allergic and injection site/infusion reactions, nausea/vomiting, diarrhea). The rates of grade 3 or 4 AEs were based on preliminary phase 3 clinical trial data for oral paclitaxel and encequidar,

package inserts for IV and protein-bound paclitaxel, and expert opinion.

Administration-related AE costs per event were derived from an oncology budget impact study. This study estimated costs of managing AEs (grade 3 or 4) by identifying each AE with specific diagnosis codes and associated resource use and costs from the Healthcare Cost and Utilization Project data.


Outcomes were assessed over a 6-month treatment duration. The primary outcomes of the model were the total costs associated with home administration of oral paclitaxel and encequidar and clinic/office administration of IV paclitaxel (175 mg/m

) and protein-bound paclitaxel per patient per month, as well as 6-month costs per patient. The outcomes were calculated for the entire duration of treatment by summing all individual component costs. All costs were inflated to 2019 US dollars using the Medical Care Consumer Price Index.

In addition, three scenario analyses were conducted for oral paclitaxel and encequidar to evaluate the impact of varying key clinical inputs on the cost of administration. These scenarios modeled varying frequencies of oncologist office visits and lab testing to demonstrate the impact on cost of home administration once oncologists gained experience with the new regimen. They were (1) decreased frequency of lab testing after 3 months of treatment initiation, (2) decreased frequency of lab testing after cy of oncologist visits and lab testing after 1 month of treatment initiation.

In this cost analysis, IV paclitaxel (175 mg/m

), the FDA-approved dose of IV paclitaxel for the treatment of mBC that is given every 3 weeks, was included to maintain consistency with the phase 3 trial of oral paclitaxel and encequidar. However, an additional “weekly IV paclitaxel” scenario was conducted in which weekly IV paclitaxel (80-100 mg/m2) was included as an alternative regimen because it is another dosage of IV paclitaxel commonly used in clinical practice for the treatment of mBC.

Univariate sensitivity analyses were conducted to determine the extent to which uncertainty inherent to the model inputs affected the modeled outcomes when the inputs were varied 1 at a time. The high and low values of clinical inputs for oral paclitaxel and encequidar (such as oncologist visits and lab testing frequencies) were based on clinical relevance determined by experts or literature. Clinical meaningfulness pertains to minimum or maximum number of oncologist/lab visits that would be required based on clinical experience, so rather than varying these variables by 30%, clinically relevant values were selected.

All other inputs were varied to 30% higher and 30% lower than the base case values to analyze the impact on results. Oncologist visits and lab testing frequencies of IV therapies were not varied in the sensitivity analyses, as schedules for those dosing regimens are well established.


The results of the base case analysis are shown in 

. The base case analyzed the per-patient per-month (PPPM) cost of home administration of oral paclitaxel and encequidar compared with clinic/office administration of IV paclitaxel (175 mg/m

) and protein-bound paclitaxel for a treatment duration of 6 months for 10,000 patients with mBC with 30% of patients covered by Medicare.

The total administration costs for oral paclitaxel and encequidar, IV paclitaxel (175 mg/m

), and protein-bound paclitaxel were $523 PPPM, $1469 PPPM (2.8 times higher than oral paclitaxel and encequidar), and $1445 PPPM (2.8 times higher than oral paclitaxel and encequidar), respectively. The difference in costs was driven largely by higher costs for administration and for premedication associated with IV therapies. The total administration cost PPPM for oral paclitaxel and encequidar was 64.4% lower than for IV paclitaxel (175 mg/m2) and 63.8% lower than for protein-bound paclitaxel.


The results of the scenario analyses are shown in 

. The 3 scenario analyses showed that with decreasing frequency of oncology office visits and lab tests, as oncologists gained more experience with the home administration of oral paclitaxel and encequidar, 7% to 28% reductions of the cost of care associated with its administration would occur in the base case analysis. For the weekly IV paclitaxel scenario, the total administration cost for weekly IV paclitaxel (80-100 mg/m2) was $2510 PPPM (4.8 times higher than oral paclitaxel and encequidar).


Detailed results of the 1-way sensitivity analysis are shown in 

shows the input variables that resulted in maximum variability in home administration of oral paclitaxel and encequidar cost PPPM. Cost (PPPM) of home administration of oral paclitaxel and encequidar varied the most when the frequency and cost of oncologist office visits, frequency of CBC lab visits, and incidence and cost of nausea/vomiting were increased or decreased by approximately 30%. By varying each model input 1 at a time, the cost of home administration of oral paclitaxel and encequidar increased by a maximum of $68 PPPM compared with the base case analysis, indicating that the model was robust.

In oncology, including mBC, cytotoxic chemotherapy is primarily administered IV rather than orally.

 The advantages of oral chemotherapy could be multifold. Compared with IV chemotherapy, it provides ease of administration with respect to timing and location (ie, home setting). Oral chemotherapy also has the potential to provide relatively prolonged treatment exposure as compared with IV infusions. Use of oral chemotherapy can potentially result in reduced health care resource utilization of outpatient infusion-related services. Overall, oral therapy could result in better quality of life than parenteral administration.

 However, oral administration of many anticancer agents, including paclitaxel, has not been possible due to poor absorption into the bloodstream due to the active excretion by P‑gp in the intestinal cells.

 Studies have shown that when administered with encequidar, a highly specific intestinal P-gp inhibitor, oral paclitaxel achieves therapeutic blood levels and is more efficacious than IV paclitaxel in patients with mBC.

In the current study, a cost calculator model demonstrated that, from a US payer perspective, home administration of oral paclitaxel and encequidar was associated with much lower total administration cost PPPM than clinic/office administration of IV paclitaxel (175 mg/m

) and proteinbound paclitaxel, assuming equal efficacy and safety other than administration-related AEs. Findings show that home administration of oral paclitaxel and encequidar may result in potential cost savings for payers. The immediate cost savings associated with oral paclitaxel and encequidar from the payer’s perspective for a 6-month treatment duration were approximately $940 PPPM compared with IV chemotherapies. The key drivers of cost savings were found to be the lower administration costs and the much lower premedication costs associated with home administration of oral therapy.

The findings from this study are consistent with those of other pharmacoeconomic studies that compared costs associated with oral vs IV chemotherapies. Cassidy et al conducted a cost-effectiveness study of oral capecitabine and IV 5-fluorouracil/leucovorin (5-FU/LV) in patients with Dukes’ C colon cancer, wherein incremental direct costs (ie, chemotherapy, treatment  administration visits, hospitalization, and management of AEs) and societal costs (ie, time and travel) were assessed. 

The study results showed that compared with 5-FU/LV, capecitabine was the dominant treatment: It was associated with almost half of the direct costs (£3176 vs £6829), one-fifth of the societal costs (£381 vs £1699), and better outcomes. Although capecitabine had higher acquisition costs, its associated costs for administration, management of AEs, and patient travel and time were much lower than those of 5-FU/LV.21 Similarly, Lay et al conducted a cost minimization analysis (assuming equal efficacy) of oral vinorelbine and IV chemotherapies (vinorelbine, gemcitabine, paclitaxel, and docetaxel) for treatment of patients with non–small cell lung cancer. They found that IV chemotherapies were associated with costs per patient that were 1.2 to 2.3 times higher than those of oral vinorelbine (£3746, £5332, £5977,and £6766, respectively, vs £2888).

Our study has numerous strengths. The model accounted for all costs related to administration of the treatments, including administration supplies and IV preparation, premedications/concomitant medications, oncologist office visits, laboratory testing, and administration-related AEs. Although real-world practice patterns for our investigational oral drug combination are not yet known, 2 rounds of thorough expert interviews were conducted with oncologists specializing in the treatment of mBC to understand the potential resource utilization and practice patterns that would be associated with this therapy. Furthermore, in-depth scenario analyses projected to be associated with increased clinical experience of prescribing this new regimen, involving variations in the frequency of oncologist and lab-testing visits, were created; univariate sensitivity analysis was also conducted to test the robustness of the model. In addition to these scenario analyses, an additional comparator—weekly IV paclitaxel (80-100 mg/m2)—was included, as it is a routinely used dose of IV paclitaxel in clinical practice. Findings from all scenario analyses showed cost savings associated with home administration of oral paclitaxel and encequidar.

Since this was an early-stage study aiming to understand costs associated only with administration of oral and IV chemotherapy in different settings, the analysis assumed equal efficacy and safety (other than administration-related AEs) among the therapies, and drug acquisition costs were not included. Differential efficacy and safety profile and inclusion of drug acquisition costs will impact the overall economic value associated with this oral regimen. Once the pricing of oral paclitaxel and encequidar has been set, additional key information for payers will be available from other economic evaluations, including budget impact analysis.

The model was constructed from the perspective of US payers; hence, only payer-related direct costs for each administration setting were included. It will be important to investigate the impact of oral paclitaxel and encequidar from a patient’s perspective. These could include both direct costs, such as out-of-pocket expenses for the chemotherapy and travel for infusions, and indirect costs, such as lost productivity associated with IV chemotherapy.

Our study had several limitations. First, only a 6-month treatment duration was assumed in the analysis given the lack of real-world data on treatment duration of oral therapy. It is possible in the real-world setting that the duration of oral chemotherapy could be longer than that of fixed-duration IV chemotherapies. Second, an assumption of 100% adherence to medication and lab testing was made. While adherence might vary in real-world practices, it was important to make this assumption in the study to understand the complete resource utilization (ie, lab testing, office visits) and costs associated with administration of agents in different settings. Third, cost inputs were derived from multiple sources. However, extensive univariate analyses were done to verify the robustness of the model. Fourth, for the private insurer costs of lab testing, mean commercial reimbursement amounts were used in the analysis. However, there could be a high variability in commercial lab testing costs. Finally, while there may be provider incentives associated with the prescribing of IV therapies, those were not included in the analysis due to high variability.

This study found that home administration of oral paclitaxel and encequidar was associated with total administration cost of $523 PPPM, a cost 64.4% lower than that of once-every-3-weeks IV paclitaxel (175 mg/m

, $1469 PPPM) and 63.8% lower than that of protein-bound paclitaxel (260 mg/m

; $1445 PPPM). The findings indicate that home administration of oral paclitaxel and encequidar may result in potential cost savings for payers.

 EPI-Q, Inc (DS), Oak Brook, IL; Athenex, Inc (JW, ID), Schaumberg, IL; Mirador Global (KMF, CC), Kennett Square, PA.

: Dolly Sharma is an employee of EPI-Q Inc, which received payment from Athenex associated with the development and execution of this study. Jeffrey Wojtynek and Igoni Dokubo are employed by and hold stock in Athenex, which funded the study. Kathleen M. Fox and Chelsea Cooper are employees of Mirador Global, which received payment associated with the execution of this study.

This study was sponsored by Athenex, Inc.

 Concept and design (DS, JW, KMF, CC, ID); acquisition of data (DS); analysis and interpretation of data (DS, JW, KMF, CC, ID): drafting of manuscript (DS); critical revision of manuscript for important intellectual content (DS, JW, KMF, CC, ID); obtaining funding (JW, KMF, ID); administrative, technical, and logistical support (DS); and supervision (JW, KMF, CC, ID).

 Dolly Sharma, PhD (dolly.sharma@epi-q.com).

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12. Physician fee schedule search. CMS. Accessed January 3, 2020. https://
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Peer-Reviewed

Home administration of oral paclitaxel and encequidar is associated with potential cost savings for payers compared with clinic administration of intravenous chemotherapy in metastatic breast cancer patients.

Cost of Home vs Clinic Administration of Paclitaxel in Metastatic Breast Cancer

Supplemental Material: Cost of Home vs Clinic Administration of Paclitaxel in Metastatic Breast Cancer

Intravenous (IV) taxanes for metastatic breast cancer (mBC) are associated with toxicities, such as chemotherapy-induced peripheral neuropathy (CIPN), which can detrimentally impact outcomes.

 To assess the impact of CIPN on clinical and economic outcomes in women with mBC, initiating IV paclitaxel/ nab-paclitaxel.

 Adult women in the MarketScan Commercial and Medicare Supplemental Database with a mBC diagnosis, initiating IV paclitaxel or IV nab-paclitaxel (index date = first administration) from November 1, 2013, to September 30, 2018, who had no prior neuropathy diagnoses, and continuous enrollment 12 months prior to and ≥ 3 months following index were selected. Propensity score–matched CIPN and non-CIPN cohorts were defined, based on postindex CIPN diagnosis. Clinical characteristics and all-cause and breast cancer (BC)-related health care utilization and costs per patient per month (PPPM) were compared between matched CIPN and non-CIPN cohorts during follow-up.

 Among the 5870 women with mBC initiating IV paclitaxel/nab-paclitaxel, 42.7% developed CIPN. The matched cohorts each included 1950 women. Patients with CIPN were more likely to have a dose reduction (46.1% vs 38.2%, P < .001) or develop depression, diabetes, insomnia, liver dysfunction, or arthritis compared with the non-CIPN cohort, P < .05. Patients with CIPN were more likely to have an inpatient admission (39.2% vs 34.9%, P < .01) or emergency department visit (46.7% vs 35.6%, P < .001), as well as all-cause and BC–related costs that were $1102 and $725 PPPM higher, respectively, than women without CIPN (P < .01).

 CIPN was common in women, following IV paclitaxel/nab-paclitaxel treatment and was associated with dose reductions, the development of comorbidities, and elevated health care costs. Therapies for mBC that offer increased tolerability are needed to help improve patient outcomes and control costs.

 2021;27(Spec 1). Published online December 23, 2020. 

Women with metastatic breast cancer (mBC) who develop chemotherapy-induced peripheral neuropathy (CIPN) after initiating intravenous (IV) paclitaxel or IV nab-paclitaxel, utilize more health care services and incur increased costs compared to women who do not develop CIPN. Patients with CIPN also experience an increased comorbidity burden and more treatment alterations in comparison to patients without CIPN. Treatments for mBC with reduced rates of CIPN are needed, to help improve long-term outcomes and reduce the burden on the health care system.

42.7% of women developed CIPN following initiation of IV paclitaxel/nab-paclitaxel

Incremental all-cause and breast cancer-related health care costs were higher for patients who developed CIPN by $1102 and $725 per patient per month (PPPM), respectively.

Despite advancements in therapy, metastatic breast cancer (mBC) remains incurable. Treatment is focused on palliative care, with goals of prolonging survival and improving quality of life (QOL).

 Intravenous (IV) taxanes are some of the most active chemotherapies for the treatment of mBC.

 However, taxanes are largely nonspecific and associated with treatment-related toxicities, the development of which can result in treatment alterations (eg, dose reductions and regimen changes) or delays.

Chemotherapy-induced peripheral neuropathy (CIPN), which has been reported in >60% of patients with mBC treated with IV paclitaxel, is a common taxane toxicity.

 It is characterized by sensory and/or motor manifestations driven by peripheral nerve damage. The condition is believed to be caused by the loss of neuronal microtubule function, although solvents used in IV taxanes have also been implicated.

 The development of CIPN is dose-dependent and schedule-dependent; effects can also be cumulative and limit future treatment by requiring dose reductions, delays, or discontinuations.

 Furthermore, CIPN can become a chronic condition, leaving patients with long-term effects, including numbness, disability, and neuropathic pain.

In addition to their impact on patient outcomes, treatment-related toxicities, like CIPN, can place an increased burden on the health care system. Studies have reported increased costs for patients with chemotherapy-related toxicities compared to those without.

These costs can be substantial, with increases of up to 70% in monthly all-cause expenses when toxicities occur.

Although studies have assessed treatment-related toxicities in mBC, few have been focused specifically on CIPN.

 Similarly, analyses of CIPN have not been focused specifically on mBC.

 This retrospective analysis examined the clinical and economic burden of CIPN in patients with mBC, initiating IV paclitaxel or IV nab-paclitaxel.

This retrospective cohort study utilized deidentified data from the US IBM MarketScan Commercial and Medicare Supplemental databases from November 1, 2012, to December 31, 2018. The commercial database contains the inpatient, outpatient, and outpatient pharmacy details of employees and their dependents, covered under a variety of health plans. The Medicare database contains the full health care details (medical and pharmacy) of retirees with Medicare supplemental insurance provided by employers, including both Medicare-covered and employer-paid portions.

Disability data were obtained from the MarketScan Health and Productivity Management Database from November 1, 2012, to December 31, 2017 (end of available data). This database contains short-term and long-term disability data for a subset of patients in the MarketScan Commercial and Medicare Supplemental Databases. All study data were obtained using codes from the International Classification of Diseases, Ninth and Tenth Revisions, Clinical Modification (ICD-9-CM and ICD-10-CM); Current Procedural Terminology Fourth Edition; Healthcare Common Procedure Coding System; and National Drug Codes.

Adult women with greater than 1 inpatient claim, or greater than or equal to 2 nondiagnostic outpatient claims for breast cancer (BC) (ICD-9-CM: 174. xx; ICD-10-CM: C50.xx) were identified within the MarketScan Commercial and Medicare Database from January 1, 2014 to September 30, 2018. Eligible women had greater than or equal to 1 nondiagnostic claim for metastasis occurring 60 days prior to the first BC claim, through the end of data (excluded codes for metastasis to the breast). The index date was that on which the first IV paclitaxel or nab-paclitaxel was administered (identified via the Healthcare Common Procedure Coding System [HCPCS]; hereafter referred to as IV paclitaxel/nab-paclitaxel). Continuous enrollment was required for 12 months prior to, and 3 or more months following the index date. Women who had undergone taxane treatment or had a neuropathy diagnosis (

) in the preperiod were excluded, as were patients with greater than 1 taxane administration on the index date.

Patients with CIPN had 1 or more nondiagnostic claims with a diagnosis of neuropathy, paresthesia, myalgia, or arthralgia during follow-up, and were continuously enrolled for 3 or more months following the first neuropathy claim (to assess post-CIPN costs). Patients without CIPN had no neuropathy diagnoses during the study period. The final CIPN and non-CIPN cohorts were propensity score–matched based on preperiod characteristics, to control for demographic and clinical differences between groups. Covariates included evidence of any inpatient admission, length of follow-up, National Cancer Institute Charlson Comorbidity Index (NCI-CCI), use of neurotoxic agents, number of toxicities, number of chemotherapy agents administered, and evidence of endocrine therapy, radiation therapy, or BC–related surgery. A 1:1 match was implemented, with the nearest neighbor technique without replacement (

The preperiod was the 12 months preceding the index date. Outcomes were assessed over the follow-up period, which extended from the study index date until the earliest of the following: (1) administration of docetaxel; (2) end of continuous enrollment; or (3) end of the study period (December 31, 2018). For patients with CIPN, follow-up included the duration both prior to, and following the diagnosis of CIPN.

The index line of therapy (LOT) included chemotherapies administered in the 37 days following index. Non-taxane chemotherapies included capecitabine, carboplatin, cisplatin, cyclophosphamide, doxorubicin, epirubicin, eribulin, fluorouracil, gemcitabine, ixabepilone, methotrexate, and vinorelbine. The 37-day period allowed the inclusion of concomitant medications administered on a different cycle. The end of the Index LOT was defined by a change in the regimen (switch, augmentation, or drop) or the end of follow-up. Discontinuation of a regimen component was defined as a treatment gap of 45 days or more.

The IV paclitaxel/nab-paclitaxel dose changes were assessed during the Index LOT. Dose was estimated by dividing the paid amount on IV paclitaxel/nab-paclitaxel claims by the wholesale acquisition cost. Capitated claims, claims with a JW modifier, indicating medication waste, or a $0 paid amount were excluded. To assess dose changes over time, only patients with 3 or more non-$0 claims for IV paclitaxel/nab-paclitaxel were included. The magnitude of a dose change was defined as greater than or equal to 10% of the index dose. Changes were examined in relation to the prior dose.

Patient Characteristics and Comorbidities

Demographics were measured on the index date. During the preperiod, the NCI-CCI was calculated.

 Prevalent comorbid conditions were assessed during the preperiod and follow-up. During follow-up, incident comorbidities were examined among patients who did not experience the specific comorbidity during the preperiod.

Health Care Resource Utilization and Costs

All-cause and BC–related health care resource utilization and costs per patient per month (PPPM), including inpatient admissions, outpatient medical encounters (emergency department [ED] visits, outpatient office visits, and other outpatient services), and outpatient prescriptions were reported during follow-up. The BC–related health care resource utilization and costs were defined using inpatient admissions with a primary diagnosis of BC; outpatient services with a diagnosis of BC in any position; medical or pharmacy claims for BC treatments (chemotherapy, endocrine therapy, human epidermal growth factor receptor 2 [HER2] therapy, or radiation); and pharmacy claims for neuropathy medications (antidepressants, anticonvulsants, opioids and narcotics, systemic corticosteroids, nonopioid and nonsteroidal pain relief, topical local anesthetics, mexiletine, tocainide, and pentoxifylline). Costs were calculated using paid amounts on adjudicated claims. Costs for capitated plans were estimated via payment proxy. Costs were inflated to 2019 US$ using the medical care component of the Consumer Price Index.

The MarketScan Health and Productivity Management (HPM) Database was used to assess short-term and long-term disability and estimate indirect costs from November 1, 2012, to December 31, 2017. Because of the limited sample of patients with HPM data, the unmatched CIPN and non-CIPN cohorts were used for the work disability analysis. All eligible patients with available HPM data were included. The duration of the postindex period was based on the availability of HPM data that overlapped with the postindex period for the larger study. All outcomes were reported as PPPM. Indirect costs were estimated by applying an estimated daily wage to short-term or long-term disability days. Wages were calculated using sex and region-matched data from the US Bureau of Labor Statistics in 2017. Short-term and long-term disability was set as 70% and 60% of the wage rate per day, respectively.

Continuous variables were reported as mean and standard deviation. Categorical variables were reported as frequencies and percentages. All data analyses were conducted using the WPS version 4.1 (World Programming, United Kingdom).

Of the 5870 women with mBC, initiating treatment with IV paclitaxel/nab-paclitaxel, 2509 (42.7%) were diagnosed with CIPN during follow-up. The mean time from index to CIPN diagnosis was 198.9 (± 231.5) days. After matching, the CIPN and non-CIPN cohorts each comprised 1950 women, and the cohorts were well matched (

). The average follow-up was similar at 21.0 (± 12.1) months in the CIPN cohort, and 20.6 (± 12.9) months in the non-CIPN cohort. The time to first CIPN diagnosis was 169.4 (± 194.1) days, and 46.7% of the participants were diagnosed with CIPN during the Index LOT.

Most patients initiated IV paclitaxel (Table 1). Only 8.7% of the CIPN cohort and 11.9% of the non-CIPN cohort initiated IV nab-paclitaxel. The majority of patients with CIPN (82.9%) and those without CIPN (84.3%) received IV paclitaxel/nab-paclitaxel monotherapy. The duration of the Index LOT was also similar between cohorts at 96 (± 64) days in the CIPN cohort and 99 (± 63) days in the non-CIPN cohort. Patients with CIPN were more likely to end the Index LOT by dropping a medication (84.4% vs 81.2%, P = .010), whereas patients without CIPN were more likely to end the Index LOT because follow-up had come to an end (5.7% vs 2.3%, P < .001).

IV Paclitaxel/nab-Paclitaxel Dose Changes

Over 75% of the study participants qualified for the dose change analysis (CIPN, 77.4%; non-CIPN, 82.2%). Patients with CIPN were significantly more likely to undergo a dose reduction ≥ 10% during the Index LOT (46.1% vs 38.2%, P < .001, 

Among patients with a dose reduction, no significant differences were observed in the total number of, time to, or magnitude of dose reductions between cohorts (Table 2). However, patients with CIPN were more likely to receive a medication for neuropathy in +/- 10 days of a dose reduction, compared to patients without CIPN (40.8% vs 34.6%, P < .05).

Preperiod comorbidity burdens were similar between cohorts (Table 1). During follow-up, patients with CIPN had a significantly higher prevalence of depression, liver dysfunction, nonrheumatoid arthritis, insomnia, rheumatoid arthritis, falls, and fractures, compared to patients without CIPN (P < .05, 

). The CIPN cohort also had a significantly higher proportion of patients with incident depression, diabetes, insomnia, falls, fractures, liver dysfunction, and nonrheumatoid arthritis (P < .05, Table 3).

All-Cause Health Care Utilization and Costs

Patients with CIPN had higher health care service utilization and direct all-cause costs PPPM over the follow-up. They were also more likely to have 1 or more inpatient admissions (39.2% vs 34.9%, P < .01) or ED visit (46.7% vs 35.6%, P < .001) compared to patients without CIPN (Table 4). Patients with CIPN also showed a significantly greater number of monthly ED visits, office visits, other outpatient services, and outpatient pharmacy refills over follow-up (Table 4).

Greater utilization of health care services translated to increased all-cause health care costs PPP for patients with CIPN compared to patients without CIPN. During follow-up, patients with CIPN incurred total all-cause health care costs that were $1012 PPPM higher, compared to patients without CIPN ($11,181 ± $10,240 vs $10,169 ± 10,029, P < .01). The higher costs for patients with CIPN were derived from a significantly higher number of office visits, outpatient services, and outpatient pharmacy costs (

BC–Related Health Care Utilization and Costs

The CIPN cohort had significantly higher utilization of BC–related services and health care costs PPPM over follow-up. A significantly higher proportion of the CIPN cohort had 1 or more BC–related ED visits (19.3% vs 13.2%, P < .001); office visits (98.6% vs 97.3%, P < .01); or outpatient pharmacy refills for either a BC (56.0% vs 51.8%, P < .01) or neuropathy medication (93.3% vs 86.3%, P < .001) compared to the non-CIPN cohort. Patients with CIPN also had a significantly higher number of monthly office visits and outpatient pharmacy refills for BC or neuropathy medications (P < .01) (Table 4).

Higher utilization of BC–related outpatient medical and pharmacy services by the CIPN cohort led to an incremental cost for BC–related services of $725 PPPM, compared to the non-CIPN cohort. Increases in office and other outpatient services costs were the primary drivers of elevated costs (Table 4).

A total of 274 patients with CIPN and 314 patients without CIPN qualified for the short-term disability analysis. A greater proportion of patients with CIPN had a short-term disability claim during follow-up (58.0% vs. 42.0%, P < .001). No significant differences in lost workdays (CIPN, 5.1 ± 16.2; non-CIPN, 3.9 ± 11.0, P = .28); or indirect costs (CIPN: $702 ± $2185; non-CIPN: $539 ± $1657, P = .31) were observed between the cohorts. A total of 255 patients with CIPN and 288 patients without CIPN were included in the long-term disability analysis. No differences were observed between cohorts in the proportion of patients with a long-term disability claim (CIPN, 11.0%; non-CIPN, 12.0%, P = .567); the number of lost work days (CIPN, 1.3 ± 12.0; non-CIPN, 1.0 ± 3.8, P = .69); or indirect costs (CIPN, $169 ± $1586; non-CIPN, $122 ± $461, P = .63).

This claims-based study examined the burden of CIPN in patients with mBC, initiating IV paclitaxel/nab-paclitaxel. Among the 5870 women with mBC 42.7% developed CIPN over an average of 24.7 (± 13.7) months. The rate of CIPN identified in our study is higher than that of other claims-based studies, which report rates of peripheral neuropathy of less than 20%; there are several reasons for this difference

 First, our analysis allowed patients to have prior, non-taxane chemotherapy, which may be associated with an increased risk of CIPN compared to studies limiting analyses to the first or second LOT.

 Second, our follow-up extended beyond the line of IV paclitaxel/nab-paclitaxel treatment, leading to a longer follow-up than studies that assessed toxicities during a LOT. Thus, the current findings provide new insight on the longer-term impact of CIPN in mBC.

Fewer than half the patients with CIPN in our analysis were diagnosed with CIPN during the Index LOT. Therefore, the long-term burden of CIPN would have been underestimated if follow-up was limited to the Index LOT. Furthermore, other studies have reported that peripheral neuropathy is undercoded when assessed via ICD-9 codes.

 We used a broader CIPN definition, which included ICD-9/ICD-10 codes for peripheral neuropathy, paresthesia, myalgia, and arthralgia. These factors all likely resulted in higher overall rates of CIPN than previously reported in other claims-based analyses. However, the rate of CIPN identified in the current study is largely in line with, if not lower than, rates of CIPN reported in other retrospective, observational, or clinical trial analyses, which utilized electronic health records, patient surveys, or clinical scales to assess CIPN.

Similar to other studies, the current analysis showed that CIPN in mBC is associated with increased health care service utilization and costs. All-cause costs for patients with CIPN were higher than those for patients without CIPN by $1102 PPPM, or approximately $13,224 per patient annually. The BC–related costs for patients with CIPN were higher than those for patients without CIPN by $725 PPPM, or approximately $8700 per patient annually. Hansen et al.

 used claims to examine costs in patients with mBC treated with taxanes, based on toxicity development. The monthly costs for patients with toxicities were $1142 higher during the first LOT, and $1448 during the second LOT than similar costs for patients without toxicities.

 found incremental costs for patients with mBC and toxicities that ranged from $845 to $5320 per month depending on the treatment and LOT. Similarly, Pike et al.

 reported incremental annual costs of $16,940, or approximately $1412 per month, in patients with BC who developed CIPN, compared to those who did not. The slightly lower incremental costs observed in our analysis likely resulted from two main methodological differences. The current study defined cohorts based on the presence of CIPN alone. Therefore, our non-CIPN group likely had a higher rate of non-CIPN toxicities compared to the cohorts without evidence of any toxicity in other studies.

 This difference would likely lead to a lower incremental cost. Secondly, our analyses followed patients beyond their first LOT, resulting in a longer follow-up than most other studies.

The work disability analysis revealed limited differences between cohorts. The population comprised patients with mBC, who may be less likely to return to work owing to advanced disease, a point which cannot be overlooked when assessing disability. Similarly, Pike et al.

used employer disability data and found a nonsignificant trend for increased disability claims and disability days among patients with CIPN. Zanville et al.

 surveyed BC survivors regarding their ability to work; a greater proportion of patients reported being able to work at 1 year vs 1 month, leading the authors to conclude that patients developed coping mechanisms that facilitated a return to work with time.

An association between CIPN and QOL impairments has also been reported.

 used a patient survey and found that CIPN symptoms were significantly associated with worse functional performance, gait abnormalities, and an increased risk of falls. In the current analysis, no differences in the prevalence of fractures or falls were found between the CIPN and non-CIPN cohorts during the preperiod. Conversely, during follow-up, the CIPN cohort was significantly more likely to experience a fall or fracture compared with the non-CIPN cohort.

 also reported an increased rate of falls with more severe CIPN. Two studies reported an increased use of pain medication among patients with neuropathy following chemotherapy.

 Similarly, the current analysis showed that patients with CIPN also had increased use of neuropathy medication, many of which were also pain medications. Furthermore, Bao et al.

 reported increased rates of patient-reported anxiety, depression, and insomnia with increased CIPN severity. The current analysis mirrored this finding with an increased prevalence and incidence of depression and insomnia in patients with CIPN vs patients without CIPN during follow-up.

The study included patients with commercial or Medicare supplemental insurance. Thus, the results may not be generalizable to patients with other types of insurance or the uninsured. In addition, patients had 3 or more months of postindex enrollment, and patients with CIPN had 3 or more months of enrollment following a diagnosis of neuropathy. Thus, the results may not be applicable to patients who die shortly after the initiation of IV paclitaxel/nab-paclitaxel or a CIPN diagnosis.

Misclassification of clinical status, diagnoses, or other outcomes is possible, as administrative claims are collected for billing, and are subject to miscoding and undercoding. This may be particularly relevant when assessing CIPN as a previous study reported the undercoding of neuropathy.8 Furthermore, the lack of clinical data (eg, cancer stage, biomarkers, pain scales, etc.) makes it difficult to assess the severity of cancer or CIPN. Relative dose changes were estimated using paid amounts on claims. Changes in rebates, variability in generic agent prices, or site of administration could all affect these estimates. Conclusions in the work disability analyses were limited because of the low sample sizes. Not all patients could have been matched, as 22% of the CIPN cohort and 42% of the non-CIPN cohort were not matched 1:1.

CIPN is a common treatment-related toxicity in cancer. In this claims-based analysis, the long-term rate of CIPN in mBC was estimated at 42.7%. Development of CIPN following the administration of IV paclitaxel/nab-paclitaxel was associated with significantly higher utilization of all-cause and BC–related health care services and costs, an increased comorbidity burden, and more treatment alterations. These findings demonstrate the substantial long-term impact of chemotherapy and provide an estimate of both the patient burden and economic impact of CIPN. Considering the increasing survival of cancer populations with the availability of new treatments, the longer-term impact of toxicities, like CIPN, need to be considered throughout treatment. The development of alternative therapies with lower toxicity could provide substantial long-term benefits, not only for patients but also for the health care system. 

 IBM Watson Health, Cambridge, MA (BLB, ML, KW, HV, CLC); Mirador Global, Kennett Square, PA (KMF, CC); Athenex Inc., Buffalo, NY (JW, ID).

 Concept and design (BLB, KW, KMF, JW, CC, HV, ID); acquisition of data (BLB, KW, KMF, HV); analysis and interpretation of data (ML, KW, KMF, JW, CC, HV, CLC, ID); drafting of manuscript (BLB, ML); critical revision of manuscript for important intellectual content (KW, KMF, JW, CC, ID); statistical analysis (CLC); obtaining funding (JW, ID); administrative, technical, and logistical support (ML, KW, HV, CLC); and supervision (KMF, JW, CC, ID)

 This study was sponsored by Athenex, Inc.

 BLB, KW, and HV are employed by IBM Watson Health, which received funding from Athenex, Inc. to perform this study. ML and CLC were employed by IBM Watson Health at the time of this study. KMF and CC are employed by Mirador Global, which received research funding from Athenex, Inc. to conduct this study. JW and ID are employed by and own stock in Athenex. This research was presented in part at the 2020 Virtual Academy of Managed Care Pharmacy (AMCP) Nexus conference.

The data that support the findings of this study are available from IBM Watson Health. Restrictions apply to the availability of these data, which were used under license for this study.

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We examine the incidence and impact of chemotherapy induced peripheral neuropathy on clinical and economic outcomes in women with metastatic breast cancer initiating intravenous paclitaxel/nab-paclitaxel.

Kathleen M. Fox, PhD

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